Training to Improve Vertigo Management in Primary Care (VERTAP)

Effectiveness of a Training Intervention to Improve the Approach of Patients With Vertigo in Primary Care. VERTAP Clinical Trial.

Objectives: To verify the effectiveness of a blended course in PC to improve adherence to clinical practice guidelines.

Design: randomized community trial, by clusters (control group -CG- / intervention group -IG-) Scope: 20 PCT (primary care teams)(10 per group) Outcome variables will be: Diagnostic records (proportion of nonspecific diagnoses such as dizziness and vertigo, with respect to specific diagnoses such as BPPV, vestibular neuritis); Derivations to otorhinolaryngologist (ENT) and neurologist; Prescription of antivertiginous medications and Number of days off work caused by vertigo-related.

Statistical analysis:Descriptive statistics of all the baseline variables will be carried out and, the differences between groups in the post-intervention outcome variables will be evaluated through the t-test. In the IG, a multivariate logistic regression model will identify response patterns based on the baseline variables of professionals and centers

Study Overview

• Status: Not yet recruiting
• Conditions: Vertigo; Vertigo, Paroxysmal
• Intervention / Treatment: Other: Training on vertigo

Detailed Description

Vertigo is a prevalent pathology whose most frequent cause is benign paroxysmal positional vertigo (BPPV). Treatment of this disease are the relocation manoeuvres. Although these manoeuvres are effective in primary care (PC), they are not done routinely. Attention to other causes of vertigo in PC also has a wide margin for improvement. Objectives: To verify the effectiveness of a blended course in PC to improve adherence to clinical practice guidelines. Design: randomized community trial, by clusters (CG / IG), multicenter and open, taking as unit of allocation the primary care team (PCT). The professionals of the PCT that are in IG would receive the training at the beginning of the study and those of the control group will be offered after the conclusion of the same. Scope: 20 PCT (10 per group) selected from the "Costa de Ponent" Primary Care Directorate of the Catalan Health Institute. Variables: The outcome variables will be: Diagnostic records (proportion of nonspecific diagnoses such as dizziness and vertigo, with respect to specific diagnoses such as BPPV, vestibular neuritis); Derivations to otorhinolaryngologist (ENT) and neurologist; Prescription of antivertiginous medications and Number of days off work caused by vertigo-related illnesses during the study period. Other study variables will be characteristics of the professionals (age, sex) and centers (teachers, number of tutors, rural / urban). All the variables will be collected in an aggregated form by computerized data download during the year following the training intervention in the PCT. Statistical analysis: Following the CONSORT Cluster Guide, the baseline comparability of the two study groups will be analyzed to analyze the homogeneity. Descriptive statistics of all the baseline variables will be carried out and, the differences between groups in the post-intervention outcome variables will be evaluated through the t-test. In the IG, a multivariate logistic regression model will identify response patterns based on the baseline variables of professionals and centers. Conclusions: Positive results of the study could imply a paradigm shift in the approach to vertigo in primary care, which would be easy to extend to other areas since the most important part of the training course will be done online.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eva Peguero, MD. PHD; Phone Number: #34630053772; Email: pegueroeva@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 20 randomized primary care teams out of the 56 that make up the "Costa de Ponent" Primary Care Department that serve a population of 1.3 million people.

Exclusion Criteria:

• Primary care teams in which> 60% of their professionals have received a course on vertigo in the last 5 years will be excluded.
• Primary care teams who are not interested in participating in the study will be excluded

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Training group; The professionals of the primary care teams that are in Intervention group would receive the training at the beginning of the study	Other: Training on vertigo; Online training on vertigo management in primary care with a face-to-face session. On the one hand, the course will contain theoretical content and clinical cases will be used as the methodology of the course, with feedback paths for each correct or incorrect answer from the students and videos recorded expressly for the course. In addition, there will be a face-to-face session where all participants must perform the diagnostic and therapeutic maneuvers proposed in the course, to evaluate the use of the training and also to standardize the way of doing them for the study
No Intervention: Common Practice; The professionals of the primary care teams that are in Control group will be offered the training after the conclusion of the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic records	proportion of nonspecific diagnoses such as dizziness and vertigo, with respect to specific diagnoses such as BPPV, vestibular neuritis	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Derivations to otorhinolaryngologist (ENT) and neurologist	Number of referrals made during the study period	one year
Prescription of antivertiginous medications	Number of prescriptions of betahistine, sulpiride, dimenhydrinate made during the study period	One year
Days off work	Number of days off work caused by vertigo-related illnesses during the study period	One year

Collaborators and Investigators

• Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
• Collaborators: Instituto de Salud Carlos III; Catalan Society of Family Medicine
• Investigators: Principal Investigator: José L Ballve, MD, PHD, IDIAP Jordi Gol

Publications and helpful links

General Publications

• Patino JEP, Moreno JLB, Matos YR, Ortega JA, Puertolas OC, Munoz RC, Balboa IV, Compta XG, Agudelo OLA, Munoz SC, Rodriguez VM, Cortes AN, Rodriguez EP. Effectiveness of a training intervention to improve the management of vertigo in primary care: a multicentre cluster-randomised trial, VERTAP. Trials. 2022 Jul 29;23(1):608. doi: 10.1186/s13063-022-06548-7. Erratum In: Trials. 2022 Sep 21;23(1):793.

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2021
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: June 7, 2021
• First Submitted That Met QC Criteria: June 10, 2021
• First Posted (Actual): June 18, 2021

Study Record Updates

• Last Update Posted (Actual): June 18, 2021
• Last Update Submitted That Met QC Criteria: June 10, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: vertigo; primary care; randomized clinical trial
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Labyrinth Diseases; Ear Diseases; Vestibular Diseases; Sensation Disorders; Vertigo; Dizziness
• Other Study ID Numbers: 4R21/003; PI19/00736 (Other Grant/Funding Number: Instituto de Salud Carlos III)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No